Quality Assurance (QA) Project Support - Randstad : Job Details

Quality Assurance (QA) Project Support – Contract Position

Location: Raleigh, NC (On-Site)

Contract Duration: 6 months (with potential for extension)

Start Date: March 31, 2025

About the Role

Biogen is seeking a Quality Assurance (QA) Project Support professional to assist in the Large-Scale Manufacturing (LSM) Modernization Project. This initiative aims to implement a new Manufacturing Execution System (MES), including electronic equipment tracking, electronic batch records, and release by exception functionalities. The selected candidate will play a key role in ensuring operational readiness and successful integration of the MES system into routine production.

Key Responsibilities

• Support operational readiness efforts to prepare for MES implementation.
• Assist the QA team with documentation creation, updates, and reviews.
• Provide meeting support and contribute to design discussions by offering recommendations for improvements and compliance.
• Support batch record traceability mapping and other quality-related assignments as required.
• Work directly with the newly implemented MES system and associated documentation.
• Ensure adherence to regulatory requirements (FDA, EMA) and GMP standards.

Qualifications & Skills

Education:

• Bachelor's degree in Science, Engineering, or a related technical field.

Experience:

• Minimum 5+ years of experience in Quality Assurance (QA) or Quality Operations within the pharmaceutical or biotech industry.
• Experience in large molecule, drug substance manufacturing.
• Familiarity with MES or electronic batch records (preferred).
• Strong knowledge of FDA, EMA, and regulatory compliance requirements.
• Experience working within a highly regulated, compliance-driven setting.

Technical & Soft Skills:

• Strong analytical, problem-solving, and organizational skills.
• Ability to work cross-functionally with various teams.
• Proficiency in MS Office; experience with myCIMS or Veeva is a plus.
• Excellent communication and interpersonal skills.
• Ability to manage multiple tasks in a fast-paced environment.

Work Environment & Schedule

• On-site position at Biogen's Raleigh, NC manufacturing facility.
• Standard Monday–Friday work schedule with occasional overtime as needed.
• Frequent interaction with project teams, contractors, and site operations staff.
• Ability to work in an open office environment with potential distractions.

Why Join Us?

This is an exciting opportunity to contribute to a high-impact modernization project within a leading biopharmaceutical company. If you have a strong background in quality operations, regulatory compliance, and manufacturing execution systems, we encourage you to apply!

Apply today to be part of this transformative initiative!